16  |  Vaping Advocate


n May 10, 2016, the FDA issued its long-awaited 
Deeming Regulation ushering in a brand new era of 
backwards thinking on technology and public health. The 
FDA simply ignored all of our industry’s comments on 

their proposed regulations, giving little consideration to the advances 
in vapor technology, the industry’s survival as a whole, or the 
broader objective of advancing public health. 

Instead, with great fanfare, the FDA appeared from behind the 
curtain, stood before the cameras and declared that after more 
than two years of contemplation, they were proud to announce their 
“new” rules. Let’s be clear: there is nothing “new” about the FDA’s 
antiquated regulations which perpetuate in the worst way the notion 

that “we regulate because we can.”In all likelihood, the FDA knows 
that its “new” rules could very well jeopardize public health. All you 
need to do is read the public statements about the potential positive 
impact that vapor products could have on the individual and the 
population that are made by FDA leadership.In fact, the FDA’s own 
Mitch Zeller, a life-long anti-smoking advocate, appeared before 
a Senate Health, Education, Labor and Pensions Committee and 
testified, “If we could get all those people [who smoke] to completely 
switch all of their cigarettes to noncombustible cigarettes, it would 
be good for public health.”

So, let’s ask a few basic questions: Why now? What were they 
thinking? And, what are WE going to do about it.



Why after two-plus years did the FDA act on May 5, 2016?  Well, 
frankly, the FDA couldn’t handle yet another major medical group’s 
pronouncement that, based on an extensive review of all the 
available scientific, peer-reviewed literature,the risk profile of vapor 
products is no more than 5%, and probably substantially less than 
5% when compared to the risk profile of tobacco cigarettes. And, 
the FDA couldn’t risk another report from Public Health England – 
Great Britain’s equivalent of our Department of Health and Human 





National Legislative Director, 

Vapor Technology Association 


Mitch Zeller

Head Of the Center For 

Tobacco Products

Vaping Advocate

  |  17

review. Putting aside the fact that these applications create an 
unprecedented paperwork burden on small businesses, they will 
create an avalanche of requests the FDA will simply be unable to 
process, especially in the mere 12 months that the FDA has given 
itself to do so. Remember, only recently was the FDA able to rule on 
its first PMTA for products which were already well-known and for 
which there was already extensive population-based research, in a 
product category familiar to the agency.



Without changing the predicate date, the vapor industry as we know 
it will move from deemed to doomed. Literally, thousands upon 
thousands of small businesses, a/k/a job creators, will be forced 
to shut their doors. Fortunately, we already have the Cole-Bishop 
Amendment, which cleared its first major hurdle in Congress on April 
19, 2016. During a mark-up of the Agriculture, Rural Development, 
Food and Drug Administration bill, Representatives Tom Cole (R-OK) 
and Sanford Bishop (D-GA) offered a bipartisan approach that would 
accomplish the goal of protecting small businesses and preserving 
the industry, while setting the stage for commonsense regulations 
that will protect youth and ensure the safety of consumers. This is 
exactly the type of legislative solution that we need. Unlike the FDA’s 
one-size-fits-all approach, the Cole-Bishop approach seeks to 
regulate vapor products as the new technology they are, not as the 
tobacco products that they are not.

As of this writing, the Cole-Bishop Amendment is the only immediate 
vehicle that can change the predicate date to save the vapor 
industry. The Cole-Bishop Amendment brings the predicate date 
forward to 2016, thereby enabling everyone to continue to sell 
and buy existing products on the market. This is why we have 
consistently been calling for all to support Rep. Cole and Rep. 
Bishop’s bipartisan amendment with the loudest voice our collective 
vapor community can muster.

This is and has always been the first phase of saving vapor 
and protecting consumers. If passed as part of the Agricultural 
Appropriations bill, the Cole-Bishop Amendment will literally keep 
everyone in business and immediately implement common-sense 
regulations that will protect consumers and youth. Our living, 
breathing industry, even if curtailed somewhat by the spectre of a 
suffocating Deeming, still will be vibrant and empowered to carry on 
the fight.  Then, as the FDA continues to try to slam the proverbial 
square peg into the round hole, we will embark on something as 
innovative as our products: crafting and passing a rational regulatory 
regime that promotes innovation and technology and that protects 
adult consumers and youth alike. At the same time, we will expose 
the remarkably unfair status quo in which our new game-changing 
technologies are treated farworse thanall forms of combustible 
tobacco products.

We are built for this battle. We are up to the task. Join 

us in this fight!

Services –proclaiming for a third year in a row that, based on their 
independent scientific review of all the research, that we should 
be promoting rather than quashing the hope of vapor products. 
Knowing that more and more public health voices would continue 
to undercut their planned adverse action against the entire vapor 
industry, the FDA had to act.

Less than one month after the Royal College of Physician’s latest 
declaration that vapor products are, by all accepted standards, 
safe enough to be relied upon by millions of addicted smokers, 
the FDA stood before the cameras to announce their “new” rules. 
Remarkably, they did not lead with the proclamation that today was 
a great day for public health. Rather, they used the oldest play in the 
book claiming that their rules will protect the children.

In some of the very first words uttered at their press conference, the 
FDA proclaimed that they were going to protect youth by banning 
the sale of vapor products to minors. But, the FDA failed to mention 
that virtually every state already bans sales to minors. In the same 
breath, the FDA proclaimed that its“new” rules will protect children 
by implementing in Augustchild resistant packaging requirements. 
But, once again, the FDA failed to mention that, with the help of the 
vapor industry, Congress already made child resistant packaging 
the law of the land effective July 1 of this year. Given the real 
negative impact that the Deeming could have on public health, it is 
obvious why the FDA took credit for protecting youth in ways that 
they already are protected, especially when you consider the Royal 
College’s conclusion that vapor products are NOT a gateway to 
traditional tobacco.




Instead, the FDA has targeted for extinction the overwhelming 
majority of companies that manufacture or supply vapor products 
to millions of adult smokers. At best, the FDA’s “new” rules 
demonstrate callousness to the millions of adult consumers of 
cigarettes by eradicating consumer choice.  At worst, the FDA’s 
“new” rules directly threaten the health and well-being of millions of 
Americans by first wiping out a decade of technological innovation 
and then forcing consumers who rely on these products to choose 
between returning to traditional tobacco cigarettes or living off of 
what could become a robust black market.Not only is the FDA’s 
recent action a dereliction of its duty to the public, the “new” rules 
reflect just how ill-equipped FDA is to regulate microchips, electronic 
circuits, and batteries. Truly, given all that went into the Deeming, 
FDA has demonstrated a significant lack of vision for how to regulate 
a revolutionary technology, much less some of the most innovative 
companies in the world that are driving that technology forward. 
You see, FDA’s rules work for cigarettes because, for more than 
four decades, the only “innovation” in that segment has been the 
introduction of a filter.

To say that the FDA is ill-equipped to handle the very regulations 
it has chosen to implement is an understatement. The FDA is 
sitting on 3,500 provisional substantial equivalence applications 
that have been filed and for tobacco products that are currently on 
the market. These applications, which have not been ruled on by 
FDA, have been pending for up to 5 years. To make matters worse, 
through FY2015, an additional 2,000 new substantial equivalence 
applications have been languishing at the FDA awaiting a decision. 
Now, if the FDA gets its wish, vapor companies will be submitting 
tens (perhaps hundreds) of thousands of substantial equivalence 
and premarket tobacco product applications (PMTAs) for FDA